On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register (82 Fed. Reg. 51582) stating that it was withdrawing its January 19, 2017, proposed rule on the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms to “update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by [GE] organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks” (82 Fed. Reg. 7008). Citing comments on the proposed rule critical of the proposed revisions, USDA stated it is committed to “explor[ing] a full range of policy alternatives” instead, and that it will “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.” More specific comments from USDA and the reasons supporting its decision are set forth in the notice.

While it appears that some in industry may welcome the withdrawal, most would agree that all stakeholders should work collaboratively and quickly to develop a new framework to speed the process to market, and to ensure the regulatory landscape is more efficient and clearer than it currently is. USDA and pertinent others should immediately begin another process to enable the regrouping to begin.

Auburn University, which received $481,539 to develop and optimize the hydrothermal liquefaction of lignin (HTL) chemical stream and to determine the best way to modify epoxy-based resins with the lignin derived material;

University of Georgia, which received $472,965 to develop new markets, products, and processes using activated carbon monolith catalysts produced from wood and to generate value added products from platform chemicals derived from agricultural and forest resources;

Iowa State University, which received $482,905 to further develop the engineering of the membrane of microbial cell factories to improve production of biobased fuels and chemicals;

Ohio State University, which received $482,448 to improve the efficiency, costs, and emissions of the feedstock supply system for cellulosic biorefineries by conjointly supplying corn grain and stover; and

University of North Texas, which received $482,905 to improve the efficiency of the pyrolysis production of biomass and product quality for biofuel and activated carbon from self-activation process.

University of Arizona, which received $7,026,000 for the cultivation of two desert-dwelling feedstocks, specifically guayule and guar, that can provide biomass year round for biofuel production;

University of Florida, which received $7,026,000 for the development of a resilient Brassica carinata-based biofuel and bioproduct supply chain in the Southeast;

University of Missouri, Rolla, which received $32,000 to help develop a viable market for guayule resin through laboratory and field research, and expand the research and educational capacity of the asphalt laboratory at the Missouri University of Science and Technology;

North Carolina State University, which received $2,750,000 to prepare a diverse group of college students and high school teachers with the knowledge and interdisciplinary tools necessary to advance the future of America's bioenergy, bioproducts, and the bioeconomy;

The Ohio State University, which received $2,750,000 to create a national network of universities, industry, and government agencies that derive sufficient benefits to be sustainable long-term; and

Oklahoma State University, which received $1,500,000 to educate the next generation of engineers and scientists in renewable resource utilization.

On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative. The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from8:00 a.m. to 1:00 p.m. (PST). FDA states the purpose of the public meetings is “to provide the public with an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.” This initiative, which Congress appropriated $3 million to fund, calls upon FDA to work with USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology. More information on the initiative and information on how to register for the meetings is available on FDA’s website. Comments on questions listed in the Federal Register notice, scheduled to be published tomorrow, are also being requested and can be filed in Docket FDA-2017-N-5991 on www.regulations.gov. Comments are due by November 17, 2017.

The following institutions were awarded grants for projects focused on cover crop systems for biofuel production:

USDA Agricultural Research Service (ARS) received $494,000 for the development of lupin, cereal rye, and carinata winter cover crops for biomass in the southern coastal plain;

Purdue University received $498,000 for the development of cover cropping for the development of sustainable co-production of bioenergy, food, feed (BFF) and ecosystem services (ES);

Iowa State University of Science and Technology received $498,378 for the development of perennial cover crop systems for maize grain and biomass production;

Louisiana State University Agricultural Center received $387,000 to study the feedstock production potential of energy cane-sweet sorghum rotation with a winter cover crop system; and

University of Nebraska received $500,000 to assess innovative strategies to maximize cover crop yields for biofuel across a precipitation gradient.​​​

The following institutions were awarded grants for projects focused on the socioeconomic implications and public policy challenges of bioenergy and bioproducts market development and expansion:

Auburn University received $499,886 to identify the economic barriers to biomass production, to evaluate the effectiveness of the Biomass Crop Assistance Program (BCAP) in stimulating biomass market expansion, and to explore the economic and ecosystem service implications of biomass production;

Colorado State University received $499,000 to produce a unified atlas of marginal lands in the U.S., and provide insight on the costs, potential environmental benefits, and overall practical likelihood of using those lands for biomass feedstock production;

Purdue University received $492,099 to develop a dynamic theoretical model on rejuvenating coal-power plants with biomass;

Iowa State University of Science and Technology received $499,622 to provide an integrated model-based assessment of the socioeconomic, policy, and market implications of sustainable bioenergy derived from cellulosic biomass; and

University of Missouri received $498,441 to evaluate impacts on forest resources surrounding power plants using woody biomass, assess economic impacts of wood biopower systems, and quantify tradeoffs between cost, carbon reductions, and renewable energy generation obtained by the increased use of wood biopower.

On July 20, 2017, USDA released its technology transfer report for fiscal year 2016. The report outlines the public release of information, tools, and solutions and the adoption and enhancement of research outcomes by collaborative partners and formal Cooperative Research and Development Agreements (CRADA) that occurred in 2016.

The report highlights several research initiatives by ARS scientists focused on supporting the bioeconomy, including:

Development of a new yeast strain with a unique cellulolytic enzyme that efficiently breaks down biofeedstock, shows resistance to inhibitory compounds, and eliminates the need to add other enzymes to the production process;

Engineering a yeast strain from a Brazilian ethanol plant to convert plant xylose to ethanol and then identifying a strain with excellent performance;

dentification of a strain of yeast capable of converting inulin, a major polysaccharide derived from coffee processing waste, into cellulosic ethanol;

Development of genetic methods to control the conversion of agricultural sugars to compounds called liamocins using yeast; and

Studying the use of lytic enzymes as an alternative to antibiotics for preventing and controlling bacterial contamination of fuel ethanol fermentations during biorefining.

The full report, titled “Fiscal Year 2016 Annual Report on Technology Transfer” is available on USDA’s website.

On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.” This report is a collaboration among a committee of experts including the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), the Board on Life Sciences, the Board on Agriculture and Natural Resources, the Board on Chemical Sciences and Technology, and the Division on Earth and Life Studies and sponsored by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). Lynn L. Bergeson was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system.

More information on the regulatory issues of biotechnology products is available on our biobased products blog under key word biotechnology, as well as the Bergeson & Campbell, P.C. (B&C®) regulatory developments website under key phrase biobased products, biotechnology.

DOE anticipates funding one to six awards and NIFA anticipates funding three to 14 awards, with awards ranging from $500,000 to $2 million. Concept papers are due by July 7, 2017, and full applications are due by September 22, 2017. More information on BRDI is available on DOE's Office of Energy Efficiency and Renewable Energy (EERE) Exchange website.